Page:United States Statutes at Large Volume 122.djvu/3542

 12 2 STA T .35 1 9PUBLIC LA W 11 0– 31 6— AU G .1 4, 200 8andcol l e c tsu c hf ees ,wi thout an ym odification in the r ate, for a b bre v iated a p plications, g eneric new animal drug sponsors, and generic new animal drug products at any time in such fiscal year notwithstanding the provisions of subsection ( a ) relating to the date fees are to be paid .‘ ‘(g) CREDIT I NGA ND AV AI L A B ILIT YOFF EE S . — ‘‘( 1 ) I N GENERAL.—Fees authori z ed under subsection (a) shall be collected and available for obligation only to the e x tent and in the amount provided in advance in appropriations Acts. S uch fees are authorized to be appropriated to remain available until expended. Such sums as may be necessary may be trans - ferred from the Food and D rug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salary and expenses with such fiscal year limitation. T he sums transferred shall be avail- able solely for the process for the review of abbreviated applica- tions for generic new animal drugs. ‘‘( 2 ) COLLE C TIONS AND A P PROPRIATION ACTS.— ‘‘(A) IN GENERAL.—The fees authorized by this sec- tion— ‘‘(i) shall be retained in each fiscal year in an amount not to exceed the amount specified in appro- priation Acts, or otherwise made available for obliga- tion for such fiscal year and ‘‘(ii) shall only be collected and available to defray increases in the costs of the resources allocated for the process for the review of abbreviated applications for generic new animal drugs (including increases in such costs for an additional number of full-time e q uiva- lent positions in the Department of H ealth and Human Services to be engaged in such process) over such costs, excluding costs paid from fees collected under this section, for fiscal year 2 0 0 8 multiplied by the ad j ust- ment factor. ‘‘( B )CO M PLIANCE.—The Secretary shall be considered to have met the requirements of subparagraph (A)(ii) in any fiscal year if the costs funded by appropriations and allocated for the process for the review of abbreviated applications for generic new animal drugs— ‘‘(i) are not more than 3 percent below the level specified in subparagraph (A)(ii); or ‘‘(ii)(I) are more than 3 percent below the level specified in subparagraph (A)(ii), and fees assessed for the fiscal year following the subsequent fiscal year are decreased by the amount in excess of 3 percent by which such costs fell below the level specified in subparagraph (A)(ii); and ‘‘(II) such costs are not more than 5 percent below the level specified in subparagraph (A)(ii). ‘‘(3) A U T H ORI Z ATION OF APPROPRIATIONS.—There are authorized to be appropriated for fees under this section— ‘‘(A) $4 ,831,000 for fiscal year 200 9 ‘‘(B) $5,10 6 ,000 for fiscal year 2010; ‘‘(C) $5,39 7 ,000 for fiscal year 2011; ‘‘(D) $5,706,000 for fiscal year 2012; and ‘‘( E ) $6,031,000 for fiscal year 2013;

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